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NCT05933603 · ClinicalTrials.gov registry record · Phase 2
Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome
A Phase 2 study of Obstructive Sleep Apnea and Down Syndrome, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05933603: Recruiting Phase 2 study of Obstructive Sleep Apnea and Down Syndrome, sponsored by University of Arizona.
NCT05933603 is a Phase 2 study of Obstructive Sleep Apnea and Down Syndrome that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 36 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05933603, a Phase 2 study of Obstructive Sleep Apnea and Down Syndrome, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced. Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.
Primary Outcome
change in number of obstructive apneas and hypopneas per hour on polysomnography from baseline (% change)
Conditions Studied
Interventions
- DRUG Atomoxetine and Oxybutynin (ato-oxy)
Study Locations (1)
Arizona
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT05933603 shows while recruiting
NCT05933603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Atomoxetine and Oxybutynin (ato-oxy) is the first listed.
NCT05933603 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT05933603 about?
NCT05933603 is a clinical study titled "Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome". This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 m...
What is the current status of trial NCT05933603?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2023-09-29. Estimated completion is 2025-12.
What conditions does trial NCT05933603 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Down Syndrome.
What interventions are being tested in trial NCT05933603?
The interventions under investigation include: Atomoxetine and Oxybutynin (ato-oxy) (DRUG).
Who is sponsoring clinical trial NCT05933603?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05933603 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05933603's enrollment target sits among peer trials
36 122nd of 155 higher than 31 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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